Job Summary
We are looking for an individual to ensure strict adherence to safety protocols SOPs and quality standards overseeing batch manufacturing activities and coordinating with various departments to maintain operational efficiency. The role involves planning and executing production activities coordinating with cross-functional teams and ensuring compliance with regulatory requirements critical for maintaining product quality and meeting production targets.
Roles & Responsibilities
You will be responsible for adherence to company safety norms policies and SOPs (Standard Operating Procedures).
You will oversee batch manufacturing activities according to e-BMR instructions and workflow ensuring submission of executed e-BMR and workflows to IPQA (In-Process Quality Assurance) department.
You will plan routine activities manpower and work allocation for production personnel supervising to produce quality products.
You will coordinate with research and development and manufacturing science and technology team for Confirmatory and Exhibit Batches.
Your role involves coordination with other departments such as warehouse HR Admin Engineering services QA QC (Quality Control) and others.
You will be accountable for timely completion of calibration preventive maintenance activities and reducing production breakdown time through coordination with engineering department.
You will participate in inventory and production planning meetings ensuring proper material and production for oral solid dosage forms.
You will initiate quality notification breakdown notification change control in SAP and review investigation reports and CAPA (Corrective and Preventive Actions) closure.
Your role extends to reviewing SOPs URS (User Requirement Specifications) protocols and reports in DOCHUB and approving workflow recipe and e-BMR in MES.
You will review market complaints perform GxP (Generally Accepted Practices) assessment system level impact assessment and CSV (Computer System Validation) qualification.
You will ensure qualification validation calibration of equipment and process validation are done as per schedule and requirements.
Your role involves review and approval Validation Qualification Documents related reports and conducting spot checks and GEMBA walk.
You will ensure initial and periodic training of department personnel is completed and review area environmental monitoring trends.
you will be responsible for maintaining overall area to meet current regulatory compliance and norms.
Qualifications :
Educational qualification : An .
Minimum work experience : 8 to 12 years
Skills & attributes :
Technical Skills
Knowledge of dispensing granulation blending compression coating capsulation inspection.
Proficiency in utilizing MES software to execute batch manufacturing activities and ensure compliance with e-BMR instructions.
Understanding of Quality Management Systems including SOPs URS and protocols to ensure adherence to quality standards.
Familiarity with SAP software for initiating quality notifications breakdown notifications and change controls facilitating effective tracking and management of production-related processes.
Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) to ensure compliance with regulatory requirements and quality standards.
Experience in coordinating the qualification validation and calibration of equipment as well as process validation activities ensuring adherence to schedule and regulatory requirements.
Behavioural skills
Leadership skills to plan allocate tasks and supervise production personnel fostering teamwork and ensuring adherence to safety norms and quality standards.
Effective communication skills to coordinate with various departments ensuring seamless collaboration and alignment of activities.
Capacity to identify and address production-related issues promptly initiate corrective and preventive actions and facilitate investigations and CAPA closure to minimize disruptions and improve processes.
Strong organizational skills to plan routine activities prioritize tasks and ensure timely completion of calibration preventive maintenance production planning and other operational activities.
Commitment to maintaining current regulatory compliance and adherence to norms to uphold product quality and safety standards.
Additional Information :
About the Department
Global Manufacturing Organisation (GMO)
At Dr. Reddys Laboratories we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence we are a leading force in the pharmaceutical industry.
We operate 19 state-of-the-art manufacturing plants across Hyderabad Vizag Baddi Mexico Shreveport and Mirfield comprising 8 OSD facilities 3 Injectables facilities and 8 API facilities.
Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1150 drug master files across key therapy areas such as Oncology Cardio-vascular Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally Hyderabad as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive meeting business imperatives and meeting our ambitious ESG goals. Building such factories of the future is integral to innovation and to build healthcare of the future.
Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.
Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
For more details please visit our career website at Work :
No
Employment Type : Full-time
Key Skills
Hyperion,Acquisition,Asset,ABAP,Basic,Activex
Experience : years
Vacancy : 1
Team Leader • Hyderabad, Telangana, India